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Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115375
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : March 25, 2009
Bristol-Myers Squibb
Information provided by:

Brief Summary:
PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Blood Platelet Disorders Drug: Clopidogrel (SR25990) Phase 2

Detailed Description:
There will be 3 blinded dose groups of 12 patients each (9 active, 3 placebo), central randomization, stratified by age (< 1 month ;1 to 24 months). There will be a comparison of ADP-induced platelet aggregation at steady state.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)
Study Start Date : January 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation

Secondary Outcome Measures :
  1. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Neonates or infants/toddlers (up to 24 months) at risk for thrombosis (e.g., Blalock-Taussig shunt or any systemic to pulmonary artery shunt, Kawasaki disease, vascular stent or any condition requiring antiplatelet therapy).

Exclusion Criteria:

  • Ongoing bleeding or increased risk of bleeding

    • Weight < 2 kg; gestational age < 35 weeks
    • Allergy to drugs
    • Current or planned anticoagulant treatment
    • Unable to receive drug enterically
    • Platelet transfusion < 7days
    • Thrombocytopenia
    • Hepatic or renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115375

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milano, Italy
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: ICD CSD Sanofi
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00115375    
Other Study ID Numbers: PDY4422
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
Additional relevant MeSH terms:
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Heart Defects, Congenital
Blood Platelet Disorders
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Hematologic Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs